A Phase 1 Multiple-Dose Escalation and Single Dose (Tablet) Study of PF-04171327 in Healthy Volunteers

A Phase 1, Active and Placebo-Controlled, Multiple-Dose Escalation Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04171327 (Part 1), and a Single Dose Pharmacokinetic Assessment of a Tablet Formulation (Part 2) in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00812825

Enrollment

Registered

2008-12-22

Start date

2009-01-31

Completion date

2009-07-31

Last updated

2009-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Safety Tolerability Pharmacokinetics/pharmacodynamics

Brief summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics (how the drug effects certain target sites of activity in the body) of escalating doses of oral PF-04171327 in healthy volunteers for 14 days (Part 1). Part 2 will evaluate the pharmacokinetics of a single 10 mg dose of the PF-04171327 tablet in healthy volunteers.

Interventions

DRUGPF-04171327

PF-0417327 will be provided as an oral solution administered at doses of 1, 3, 10 and 30 mg. If an additional cohort is required, the dose selected will not exceed 100 mg. Solution will be administered once daily for 14 days.

DRUGPrednisolone

Oral doses of prednisolone (5, 10, and 20 mg) will be administered to the first three cohorts. The fourth cohort will receive between 1 and 20 mg to be determined after the third cohort completes dosing. If an additional cohort is required, the dose selected will not exceed 40 mg. Prednisolone tablets will be administered once daily for 14 days

DRUGPlacebo

Tablets similar in appearance to prednisolone will be administered once daily for 14 days.

DRUGPlacebo Solution

Placebo solution will be administered to those volunteers who are randomized to the placebo or prednisolone arms. This will be administered orally each day for 14 days.

DRUGPF-04171327 Tablet

A single 10 mg dose of PF-04171327 tablet formulation will be administered orally to volunteers in Part 2 of this study.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy males between 18 and 55 years, inclusive. * Healthy females between 18 and 44 years, inclusive.

Exclusion criteria

* Evidence or history of clinically significant disease; * Post-menopausal women; * History of intolerance or significant adverse effects with glucocorticoids. therapy.

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of multiple doses of PF-04171327	14 days
Determination of pharmacokinetic parameters of PF-04171327 after multiple doses	14 days
Assessment of the pharmacodynamic effects of PF-04171327 on chemical and metabolic biomarkers	14 days
Evaluation of the pharmacokinetic parameters of a single 10 mg dose of PF-04171327 tablet	1 day

Secondary

Measure	Time frame
To characterize the pharmacodynamic effects of prednisolone	14 days

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026